Access Anti-HAV and Access Anti-HAV IgM Assays EU Clinical Trial Protocol (HAV-EU-11-23)
NCT ID: NCT06289868
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1409 participants
OBSERVATIONAL
2024-02-27
2024-08-29
Brief Summary
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This study will be used to obtain CE mark for both Access anti-HAV and anti- HAV IgM assays.
Detailed Description
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The testing will be performed using banked, de-identified, prospective and retrospective US leftover clinical samples, and fully-anonymized retrospective known anti-HAV IgM positive patient samples procured from sample vendors.
Conditions
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Study Design
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OTHER
OTHER
Study Groups
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At-risk and/or signs and symptoms patients of HAV infection and/or HAV test ordered patients
Frozen leftover serum samples from adult and pediatric patients:
* From subjects exhibiting either jaundice or elevated total bilirubin or elevated serum ALT enzymes and one or more primary signs and symptoms of hepatitis infection, and/or
* From subjects at-risk of HAV infection, and/or
* From subjects for whom laboratory testing for hepatitis A was ordered by their healthcare providers.
Access anti-HAV and Access anti-HAV IgM on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
Samples will be tested by comparing Access anti-HAV assay results to final anti-HAV sample status, and Access anti-HAV IgM results to final anti-HAV IgM status, according to respective instructions for use (IFU) or study guide, as applicable, to determine to determine non-reactive (NR), reactive (R), Negative, Positive or Equivocal (EQ).
For evaluation of the clinical performance of Access anti-HAV assay, all clinical samples will be tested with the reference assays DiaSorin - LIAISON® Anti-HAV and SIEMENS Healthineers Atellica® IM Hepatitis A Total (aHAVT).
For evaluation of the clinical performance of Access anti-HAV IgM assay, all clinical samples, except pre- and post-vaccinated patient samples, will be tested with the reference assays Abbott - ARCHITECT® HAVAb-IgM, DiaSorin - LIAISON® Anti-HAV IgM, and SIEMENS Healthineers Atellica IM® Hepatitis A IgM (aHAVM).
Known anti-HAV IgM positive patients
Frozen serum or EDTA retrospective known anti-HAV IgM positive leftover samples procured from sample vendors .
These samples are known Positive for HAV IgM AND at least one of the following :
* Positive HAV PCR result (within the last 28 days) OR
* Jaundice (clinical assessment OR Total bilirubin result \>3.0 mg/dL) OR
* Elevated ALT result (\> 200 IU/L)
Access anti-HAV and Access anti-HAV IgM on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
Samples will be tested by comparing Access anti-HAV assay results to final anti-HAV sample status, and Access anti-HAV IgM results to final anti-HAV IgM status, according to respective instructions for use (IFU) or study guide, as applicable, to determine to determine non-reactive (NR), reactive (R), Negative, Positive or Equivocal (EQ).
For evaluation of the clinical performance of Access anti-HAV assay, all clinical samples will be tested with the reference assays DiaSorin - LIAISON® Anti-HAV and SIEMENS Healthineers Atellica® IM Hepatitis A Total (aHAVT).
For evaluation of the clinical performance of Access anti-HAV IgM assay, all clinical samples, except pre- and post-vaccinated patient samples, will be tested with the reference assays Abbott - ARCHITECT® HAVAb-IgM, DiaSorin - LIAISON® Anti-HAV IgM, and SIEMENS Healthineers Atellica IM® Hepatitis A IgM (aHAVM).
HAV Pre- and post-vaccinated patients
Frozen serum leftovers. A first sample was collected, and the US licensed and CE-marked vaccination series administered. A second sample was collected four (4) to ten (10) weeks after the complete vaccination series has been administered according to vaccine dosing instructions.
Access anti-HAV on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
All samples will be tested pre- and post-vaccination by comparing Access anti-HAV assay results to final anti-HAV status, according to respective instructions for use (IFU) or study guide, as applicable, to determine non-reactive (NR), initial reactivity, and repeat reactivity.
For evaluation of the clinical performance of Access anti-HAV assay, all clinical samples will be tested with the reference assays DiaSorin - LIAISON® Anti-HAV and SIEMENS Healthineers Atellica® IM Hepatitis A Total (aHAVT).
Interventions
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Access anti-HAV and Access anti-HAV IgM on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
Samples will be tested by comparing Access anti-HAV assay results to final anti-HAV sample status, and Access anti-HAV IgM results to final anti-HAV IgM status, according to respective instructions for use (IFU) or study guide, as applicable, to determine to determine non-reactive (NR), reactive (R), Negative, Positive or Equivocal (EQ).
For evaluation of the clinical performance of Access anti-HAV assay, all clinical samples will be tested with the reference assays DiaSorin - LIAISON® Anti-HAV and SIEMENS Healthineers Atellica® IM Hepatitis A Total (aHAVT).
For evaluation of the clinical performance of Access anti-HAV IgM assay, all clinical samples, except pre- and post-vaccinated patient samples, will be tested with the reference assays Abbott - ARCHITECT® HAVAb-IgM, DiaSorin - LIAISON® Anti-HAV IgM, and SIEMENS Healthineers Atellica IM® Hepatitis A IgM (aHAVM).
Access anti-HAV on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
All samples will be tested pre- and post-vaccination by comparing Access anti-HAV assay results to final anti-HAV status, according to respective instructions for use (IFU) or study guide, as applicable, to determine non-reactive (NR), initial reactivity, and repeat reactivity.
For evaluation of the clinical performance of Access anti-HAV assay, all clinical samples will be tested with the reference assays DiaSorin - LIAISON® Anti-HAV and SIEMENS Healthineers Atellica® IM Hepatitis A Total (aHAVT).
Eligibility Criteria
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Inclusion Criteria
* Subject or legal guardian has signed the Informed Consent Form (ICF) (a minor may need to sign an Assent Form (AF) if required by IRB)
* Subjects who are willing to donate the required amount of blood
* Subjects qualified for one (1) or more of the following four (4) Cohorts:
* Signs and symptoms (S/S);
* At risk (A/R);
* Presumed S/S or A/R (HAV test ordered) and
* Acute HAV Infection (known anti-HAV IgM positive samples) - these samples are not subject to the individual informed consent and volume criteria.
* Subjects 2 years of age or older
* Subjects able to understand and willing to sign the ICF at both pre and post vaccination time points. Subject or legal guardian has signed the Informed Consent Form (a minor may need to sign an assent form if required by IRB)
* Subjects who are willing to donate the required amount of blood: 30 mL
* Subjects with no signs or symptoms of hepatitis as determined by a medical provider, no history of known exposure to HAV
* Subjects previously unvaccinated for HAV
Exclusion Criteria
* Subjects who have received experimental or investigational drugs or treatments within four weeks of phlebotomy
Note for vaccination study: Subjects were screened for anti-HAV prior to vaccination, if positive they were excluded from the study.
2 Years
ALL
No
Sponsors
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Beckman Coulter, Inc.
INDUSTRY
Responsible Party
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Locations
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Cerba Xpert
Frépillon, , France
Eurofins Biomnis
Ivry-sur-Seine, , France
Countries
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Other Identifiers
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HAV-EU-11-23
Identifier Type: OTHER
Identifier Source: secondary_id
DC-TR23-0222
Identifier Type: -
Identifier Source: org_study_id